FDA Inspection 773830 — Global Biotechnologies, Inc.
The FDA completed an inspection of Global Biotechnologies, Inc. on March 16, 2012 in Portland, ME. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 25 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 16, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Unapproved and Misbranded Drugs
- Location
- Portland, ME (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1174 | 21 CFR 211.42(b) | Product flow through building is inadequate |
| 1395 | 21 CFR 211.103 | Actual vs. theoretical yields not determined |
| 15453 | 21 CFR 111.16 | Written procedures - cleaning |
| 15454 | 21 CFR 111.16 | Written procedures - pest control |
| 15496 | 21 CFR 111.27(b) | Instruments - calibration |
| 15531 | 21 CFR 111.255(a) | Batch record - every batch |
| 15646 | 21 CFR 111.460(a) | Hold, identify - in-process material |
| 15659 | 21 CFR 111.475(b)(1) | Written procedures - holding; distributing |
| 15733 | 21 CFR 111.365 | Manufacturing operations - prevent contamination |
| 15763 | 21 CFR 111.205(a) | Master manufacturing record - unique formulation |
| 15809 | 21 CFR 111.570(b)(1) | Written procedures - product complaint; review, investigate |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15831 | 21 CFR 111.70(b)(3) | Specifications - contamination limits |
| 15832 | 21 CFR 111.70(c)(1) | In-process identity, purity, strength, composition |
| 15853 | 21 CFR 111.73 | Specifications met - identity, purity, strength, composition |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 16057 | 21 CFR 111.535(b)(1) | Records - returned dietary supplement: written procedures |
| 1833 | 21 CFR 211.84(d)(1) | Identity Testing of Each Component |
| 1885 | 21 CFR 211.165(b) | Microbiological testing |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 3561 | 21 CFR 211.56(b) | Written sanitation procedures lacking |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |
| 4352 | 21 CFR 211.160(b)(4) | Calibration - at intervals, written program, remedial action |